The Study to Evaluate Efficacy and Safety of MY-REPT Capsule in Primary, Liver Transplantation Recipients (MYLT1)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Chong Kun Dang Pharmaceutical
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01766518
First received: January 10, 2013
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

Efficacy and safety of MY-REPT capsule in primary, liver transplantation recipients


Condition Intervention Phase
Evidence of Liver Transplantation
Drug: Mycophenolate mofetil
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label, Multicenter, Non-comparative Study to Evaluate the Efficacy and Safety of MY-REPT Capsule in Primary, Liver Transplantation Recipients.

Resource links provided by NLM:


Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • Rate of acute rejection [ Time Frame: up to 26weeks ] [ Designated as safety issue: No ]
    Rate acute rejection by liver biopsy


Secondary Outcome Measures:
  • Frequency, Time, Severity of acute rejection [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ]
  • Graft loss, Patient survival rate [ Time Frame: up to 26weeks ] [ Designated as safety issue: No ]
  • Kidney function test by e-GFR(Glomerular filtration rate) [ Time Frame: up to 26weeks ] [ Designated as safety issue: No ]
  • Questionnaire of gastrointestinal symptom assessment [ Time Frame: screening visit, closing visit ] [ Designated as safety issue: No ]
  • Questionnaire of gastrointestinal quality of life index [ Time Frame: screening visit, closing visit ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Rate of adverse event [ Time Frame: up to 26 weeks ] [ Designated as safety issue: Yes ]
  • Laboratory test [ Time Frame: up to 26weeks ] [ Designated as safety issue: Yes ]
  • Physical exam, pulse rate et. [ Time Frame: up to 26weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: November 2009
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MY-REPT capsule
MY-REPT capsule: Mycophenolate mofetil, 250mg/cap, orally
Drug: Mycophenolate mofetil
MY-REPT capsule 500~1500mg/day, per oral, capsules twice a day with Tacrolimus, Corticosteroids, Basiliximab post liver transplantation
Other Name: MY-REPT capsule

Detailed Description:

Open label, Multicenter, Non-comparative Study to evaluate the efficacy and safety of MY-REPT capsule in primary, liver transplantation

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with primary liver transplantation recipients
  • Male and Female aged ≥19 and ≤65
  • Patient with ABO blood type correspond with Donor's blood type
  • Patient who agreement with written informed consent
  • Patient who Women if had childbearing potential must have a negative serum or urine pregnancy test at the screening visit and agreement with contraception

Exclusion Criteria:

  • Patient with secondary liver transplantation(LT) recipient or other organ transplantation recipient in past or current
  • Patient with multi-organ transplantation recipient
  • Patient with dual-graft transplantation recipient
  • Patient who used body artificial liver before LT
  • Cr level >2.0mg/dL in screening
  • WBC <2,000/mm3 or ANC <900/mm3 or PLT <30,000/mm3 in screening
  • Patient who experienced severe gastrointestinal disorder so investigator judge the man's participation impossible
  • Patient who experienced severe infection (need to treatment)
  • Patient or Donor with HIV positive
  • Patient who need to treat with immunosuppressant or chemistry therapy
  • Patient who had taken immunosuppressant within 30days before LT (except to take Corticosteroids and Tacrolimus due to protocol)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766518

Contacts
Contact: SungGyu Lee, Ph.D +82 2 3010 7182 sglee2@amc.seoul.kr

Locations
Korea, Republic of
Asan medical center Recruiting
Seoul, Korea, Republic of
Contact: SungGyu Lee, Ph.D    +82 2 3010 7182    sglee2@amc.ac.kr   
Principal Investigator: SungGyu Lee, Ph.D         
Samsung Medical Center Completed
Seoul, Korea, Republic of
Seoul ST Mary's Hospital Completed
Seoul, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
Principal Investigator: SungGyu Lee, Ph.D Asan Medical Center
  More Information

No publications provided

Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT01766518     History of Changes
Other Study ID Numbers: m307LTP09D
Study First Received: January 10, 2013
Last Updated: November 6, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by Chong Kun Dang Pharmaceutical:
liver transplantation
LT
Mycophenolate mofetil
MMF

Additional relevant MeSH terms:
Mycophenolic Acid
Mycophenolate mofetil
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014